The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients

NCT ID: NCT05760040

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-01-30

Brief Summary

Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Detailed Description

Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years. According to the researchers' hypotheses, Virtual Reality acts as a non-pharmacological method, using cognitive and attentional processes on the body's complex pain modulation system. Although the neurobiological mechanisms have not been fully explained in studies, it has been reported that virtual reality applications have positive results in pain management. When patients feel that they are in the image, their attention is effectively distracted from the pain. Thus, the existing perception of pain decreases.

In recent years, virtual reality as a distraction application has been used in clinical medical care to relieve pain. Virtual Reality applications; There are studies showing its effectiveness in pain and anxiety management in many areas such as burn debridement, injection applications, wound care, toothache, endoscopy procedure, phantom and chronic pain, and chemotherapy applications.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Conditions

Pain; Anxiety; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual Reality (VR)

During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.

Group Type: EXPERIMENTAL

vırtual reality

Intervention Type: OTHER

During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.

Control group

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Group Type: EXPERIMENTAL

Control Group

Intervention Type: OTHER

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Interventions

vırtual reality

During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.

Intervention Type: OTHER

Control Group

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Not having any psychiatric disease,
• Having no vision, hearing and perception problems,
• At least primary school graduate,
• Can read and write Turkish,
• Hemodynamically stable,
• No previous experience of intrauterine device application women

Exclusion Criteria

• Under 18 years old,
• Having any psychiatric disease,
• Having vision, hearing and perception problems,
• Illiterate,
• Hemodynamically unstable,
• Women who have had an intrauterine device before

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Nurdan Demirci

PhD RN, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

tuğba öz

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ford CG, Manegold EM, Randall CL, Aballay AM, Duncan CL. Assessing the feasibility of implementing low-cost virtual reality therapy during routine burn care. Burns. 2018 Jun;44(4):886-895. doi: 10.1016/j.burns.2017.11.020. Epub 2018 Jan 2.

Reference Type: BACKGROUND

PMID: 29305105 (View on PubMed)

Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.

Reference Type: BACKGROUND

PMID: 31094789 (View on PubMed)

Guo C, Deng H, Yang J. Effect of virtual reality distraction on pain among patients with hand injury undergoing dressing change. J Clin Nurs. 2015 Jan;24(1-2):115-20. doi: 10.1111/jocn.12626. Epub 2014 Jun 4.

Reference Type: BACKGROUND

PMID: 24899241 (View on PubMed)

Jin W, Choo A, Gromala D, Shaw C, Squire P. A Virtual Reality Game for Chronic Pain Management: A Randomized, Controlled Clinical Study. Stud Health Technol Inform. 2016;220:154-60.

Reference Type: BACKGROUND

PMID: 27046570 (View on PubMed)

Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2.

Reference Type: BACKGROUND

PMID: 29904806 (View on PubMed)

Matheve T, Bogaerts K, Timmermans A. Virtual reality distraction induces hypoalgesia in patients with chronic low back pain: a randomized controlled trial. J Neuroeng Rehabil. 2020 Apr 22;17(1):55. doi: 10.1186/s12984-020-00688-0.

Reference Type: BACKGROUND

PMID: 32321516 (View on PubMed)

Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available.

Reference Type: BACKGROUND

PMID: 25930099 (View on PubMed)

Other Identifiers

MarmaraU-OZ-2023

Identifier Type: -

Identifier Source: org_study_id